Conavi Medical Novasight Hybrid System Catheter Injury Lawsuit Lawyers

FDA Issues Class I Recall After Catheter Sheath Detached Inside Patient During Coronary Imaging Procedure

The U.S. Food and Drug Administration (FDA) has finalized a Class I recall involving the catheters used with the Conavi Medical Novasight Hybrid System, a medical imaging device used in coronary artery procedures. This recall followed a serious malfunction in which a catheter sheath became detached and remained inside a patient’s body during a procedure. While in that reported case the catheter was safely removed without additional injury, the potential for serious harm, including death, led federal regulators to classify the recall as the most urgent level.

A Class I recall indicates that there is a reasonable probability the device could cause serious adverse health consequences or death if it continues to be used. For patients who underwent procedures involving the Novasight system, the announcement raises urgent medical and legal concerns. People harmed by this device malfunction may face physical injury, emotional distress, unexpected medical expenses, and long‑term health implications. Many injured patients and their families may not understand their legal rights or the compensation they may be able to pursue under product liability and medical device defect claims.

This page is intended to help patients, loved ones, and caregivers understand:

• What the Novasight Hybrid System is and how it is used.
• Why the FDA issued a Class I recall.
• The specific risks posed by a detached catheter sheath.
• What legal rights do patients have following an injury.
• How can injured individuals seek financial compensation.

The recall is part of broader FDA oversight to protect patients from unsafe medical devices. At the same time, the recall does not automatically compensate those who were harmed. Patients who suffered injury may have legal options to pursue compensation from the device manufacturer and others responsible for bringing unsafe products to market. Legal action can address medical costs, lost income, pain and suffering, and other damages suffered as a result of the defective device.

What Is the Novasight Hybrid System and How Is It Used?

The Novasight Hybrid System is a medical imaging technology designed to assist cardiologists in evaluating the coronary arteries—the vessels that supply blood to the heart muscle. It combines two distinct imaging technologies into a single catheter:

• Intravascular Ultrasound (IVUS)
• Optical Coherence Tomography (OCT)

Both imaging modalities allow physicians to view internal structures of blood vessels with high precision during interventional cardiology procedures. These images help determine the severity of artery blockages, inform decisions about stent placement, and guide complex cardiovascular interventions. The combination of IVUS and OCT is intended to offer enhanced detail compared to either technology alone.

The Novasight system is used during catheterization procedures, where a small catheter is threaded into a patient’s coronary artery through an access point—typically in the groin or wrist. Once in place, the catheter gathers internal images that help guide the physician’s actions.

Because these procedures involve the heart and major blood vessels, any device malfunction can have immediate and serious effects on a patient’s health. Unlike external diagnostic tools, intravascular imaging catheters interact directly with sensitive internal anatomy. If part of the device breaks, detaches, or fails, it can cause vessel injury, inflammation, blockage, or other dangerous outcomes.

The FDA Recall: What Happened and Why It Matters

The FDA first issued an early warning about the risk involving the Novasight Hybrid System in April 2025. At that time, the agency was still gathering information and had not yet moved forward with a formal recall. After further evaluation and report of a detached catheter sheath, the FDA finalized the recall as Class I—the highest classification under federal recall standards.

What a Class I Recall Means

A Class I recall is issued when:

• Use of the product can reasonably be expected to cause serious injury or death.
• There is strong evidence that the product defect poses an imminent risk.
• The defect could result in life‑threatening complications during typical use.

This classification reflects the severity of potential harm. Catheters that detach inside the body, particularly in coronary arteries, compromise the safety of an already invasive procedure. The possibility of fragment retention, vessel damage, and subsequent medical complications underscores the urgent nature of the recall.

The FDA’s recall notice included specific lot numbers associated with the defective devices:

• 230902
• 240202
• 240302
• 240402
• 240502

Healthcare facilities that use or sell the Novasight Hybrid System have been instructed to remove affected devices from inventory and discontinue use. Conavi Medical has also distributed customer letters outlining the recall and advising clinicians to verify that affected lot numbers are not used in future procedures.

Risks of Detached Catheter Sheath: Medical Complications and Patient Harm

The primary hazard prompting the recall is detachment of the catheter sheath during an intravascular imaging procedure. In one confirmed case, the sheath separated and remained inside the patient’s artery. Although it was successfully retrieved, the agency emphasized that removal of a detached catheter inside a coronary artery carries significant risk.

Potential Impacts of a Detached Catheter Sheath

If a catheter sheath becomes detached inside a vessel, the following serious medical complications may occur:

• Coronary Artery Spasm: Sudden constriction of the artery that can restrict blood flow
• Artery Dissection: The inner lining of the artery can split, which may restrict blood flow or lead to rupture
• Perforation: The vessel wall can be punctured, causing internal bleeding
• Thrombosis: Blood clots may form at the site of detachment or retrieval
• Embolism: A detached piece may travel downstream and block smaller vessels
• Abrupt Vessel Closure: A critical artery may close unexpectedly, leading to a heart attack

Risks During Removal

Even when removal is attempted, serious issues may arise:

• Heart Rhythm Disturbances: Abnormal heart rhythms such as bradyarrhythmia (slow heart rate) or tachyarrhythmia (rapid heart rate)
• Hypotension: Significant drops in blood pressure
• Respiratory Insufficiency: Difficulty breathing during or after retrieval procedures
• Need for Cardiac Surgery: If standard retrieval methods fail, emergency surgical intervention may be necessary.

These risks extend beyond the initial malfunction and can result in long‑term health problems, extended hospitalization, increased medical expenses, and, in extreme cases, permanent disability or death.

Patients and families should be aware that potential complications are not limited to the procedure in which the defect occurred. Secondary injuries may arise from corrective interventions, prolonged treatment, and psychological trauma associated with sudden, unexpected medical crises.

Why This Recall Raises Legal Questions for Injured Patients

When a medical device causes harm due to a defect, patients may have legal rights to pursue compensation. Unlike a recall, which is intended to protect future patients, legal claims focus on those who were already injured by the device.

Who May Be Liable

Potential responsible parties in claims involving defective medical devices include:

• Device Manufacturer (Conavi Medical): Responsible for design, testing, quality assurance, and distribution
• Component Suppliers: Companies that provided parts or materials for the device
• Distributors and Importers: Entities that brought the product into hospitals and clinics
• Healthcare Providers: In certain cases, depending on their actions or omissions during use

To succeed in a claim, an injured patient must typically show that:

• The device was defective due to design, manufacturing, or inadequate warnings.
• The defect directly caused harm.
• The harm resulted in measurable damages.

Federal law also governs medical device safety and reporting standards. A manufacturer may face claims for failure to monitor post‑market performance and warn clinicians and patients of risks discovered after approval.

What Injured Patients May Be Entitled To Recover

In many defective medical device cases, injured patients may be eligible for compensation covering a range of harms.

Types of Damages in Medical Device Claims

Medical Expenses:

• Emergency care related to the malfunction
• Hospitalization costs
• Medications and additional procedures
• Rehabilitation and follow‑up care

Lost Wages and Earning Capacity:

• Time away from work for recovery
• Reduced ability to work in the future due to a lasting impairment

Pain and Suffering:

• Physical pain from injury
• Emotional distress caused by trauma and treatment

Permanent Disability Compensation:

• When the injury results in lasting physical limitations

Wrongful Death Damages:

• In situations where a patient dies due to the defect, family members may pursue compensation for loss of support, funeral expenses, and emotional damages.

The value of each claim depends on the severity of injury, the cost of treatment, and long‑term consequences. An attorney can assess these factors and build a case tailored to the injured person’s circumstances.

Steps Patients Should Take After an Injury Linked to the Novasight Device

If you or a loved one underwent a procedure involving the Novasight Hybrid System and experienced problems that may be linked to device malfunction, the following steps can help protect your legal rights:

1. Seek Immediate Medical Evaluation: Even if symptoms appear minor, prompt assessment ensures proper documentation of injury.
2. Preserve Medical Records: Retain all imaging studies, procedure reports, discharge summaries, and follow‑up care records.
3. Collect Product Information: If possible, obtain records of the device lot number used in your procedure. Hospitals may be able to provide this information.
4. Document Your Symptoms and Treatment: Keep a detailed timeline of when symptoms began and how they affected your daily life.
5. Take Photographs and Notes: Visual and written records of physical effects, scarring, or medical dressings can support your claim.
6. Avoid Discussing Your Case on Social Media: Statements online may impact legal proceedings later.
7. Contact a Medical Device Injury Attorney Promptly: Deadlines for filing claims vary by state. Early legal consultation can help preserve your rights.

Novasite Catheter Lawsuit Frequently Asked Questions

What does a Class I recall mean?
A Class I recall is the most serious recall category the FDA issues. It means that use of the device poses a reasonable probability of serious injury or death if the defect is not addressed.

I had a Novasight catheter used during my procedure. Does that mean I was harmed?
Not every device malfunction results in injury. However, if you experience complications such as chest pain, difficulty breathing, abnormal heart rhythms, or other symptoms, you should seek medical care and discuss the possibility of a device‑related injury with your doctor. A medical review is essential for diagnosis and documentation.

Who pays for medical costs if the device caused my injury?
In many cases, compensation may be available through a legal claim against the manufacturer or other responsible parties. Settlements or verdicts can cover past and future medical expenses linked to the defect.

What types of injuries have occurred from this defect?
Injury risks include vessel damage, arrhythmias, perforation, thrombosis, respiratory problems, and, in rare cases, emergency surgery or other interventions.

Can I file a lawsuit if my device malfunction did not cause immediate injury?
Potential claims may still be possible if the device defect poses a threat to health or resulted in additional medical procedures. An attorney can assess whether your situation qualifies.

Is there a time limit to file a claim?
Yes. Each state has a statute of limitations, which limits how long after the injury you can file a lawsuit. Some cases involving medical device defects may also involve complex preservation of evidence.

How long does a medical device lawsuit take?
The timeline varies. Some cases settle before trial, while others proceed through litigation. Patience and thorough case development are essential.

Do I need proof of the specific catheter used in my procedure?
Medical records, including device lot numbers and procedure notes, strengthen a claim. If this information is not readily available, an attorney may help obtain it through legal processes.

Contact Parker Waichman Llp For A Free Case Review

If you or a loved one experienced complications, injury, or unexpected medical harm after a procedure involving the Novasight Hybrid System, legal options may be available. Parker Waichman LLP, a national personal injury law firm, is actively reviewing claims related to this FDA‑confirmed recall and other medical device defects. Our attorneys can evaluate your situation, determine liability, and help you pursue compensation for medical expenses, lost income, pain and suffering, and other damages.

Call 1‑800‑YOUR‑LAWYER (1‑800‑968‑7529) today for a free consultation to discuss your potential case and learn your legal options. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.